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The NuVasive® Disposable Stimulating Electrode is indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

The Disposable Stimulating Electrode is a single-use; sterile stimulating electrode composed of polyphenylsulfone (PPSU) and a conductive silver. The Disposable Stimulating Electrode is insulated along its length with a dielectric coating, a non-insulated proximal connector to attach to any compatible neuromonitoring stimulator, and a non-insulated distal tip to deliver tissue stimulation.

The provided text describes the 510(k) summary for the NuVasive® Disposable Stimulating Electrode, focusing on demonstrating its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a clinical study with an AI component.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable or not present in the provided document.

However, I can extract the information related to the performance data provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. The document describes non-clinical testing (e.g., impedance, biocompatibility, sterilization, shelf life) rather than a clinical study with a "test set" of patient data. The purpose was to demonstrate substantial equivalence to predicate devices through technical performance and safety testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. No clinical "test set" or human expert ground truth establishment is described for this type of non-clinical, substantial equivalence testing.

4. Adjudication method for the test set:

• Not applicable / Not provided. No clinical "test set" requiring adjudication by experts is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC comparative effectiveness study was not performed. This device is a disposable stimulating electrode, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This device is a physical medical instrument, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used:

• For the non-clinical tests conducted, the "ground truth" would be defined by the validated standards and specifications themselves (e.g., ISO standards for biocompatibility/sterilization, ASTM standards for shelf-life, and pre-defined acceptable ranges for impedance and durability tests). The goal was to meet or exceed the performance of the predicate device based on these engineering and safety benchmarks.

8. The sample size for the training set:

• Not applicable / Not provided. No training set for an algorithm is relevant to this device.

9. How the ground truth for the training set was established:

• Not applicable / Not provided. No training set for an algorithm is relevant to this device.

Summary of the Study:

The study described is a non-clinical performance evaluation aimed at demonstrating that the NuVasive® Disposable Stimulating Electrode is "substantially equivalent" to already legally marketed predicate devices. This is a common pathway for 510(k) clearance. The "study" consisted of a series of laboratory and bench tests covering:

• Electrical and Mechanical Performance: Impedance and Durability Testing.
• Biocompatibility: Tests to ensure the device materials are safe for biological contact, following ISO 10993 standards.
• Sterilization: Validation of the sterilization process and assessment of residuals, following ISO and AAMI standards.
• Shelf Life: Testing to determine the stability and integrity of the device over its intended storage period, following ASTM and ISO standards.

The "proof" that the device meets the acceptance criteria is stated as: "The results of these studies showed that the subject Disposable Stimulating Electrode meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent." No specific quantitative results are provided in this summary, but it confirms that the tests were conducted and the performance was deemed acceptable in comparison to predicate devices, thereby enabling its clearance by the FDA.

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